MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BIOPSY VALVE

Model Number	MB-358
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned as it was disposed off at the facility.There was no device evaluation.The customer provided the cleaning, disinfection, and sterilization process and stated that there have been no deviations, deficiencies or concerns relating to the device reprocessing.Precleaning was performed immediately after the procedure.Air/water was aspirated through the instrument/suction channel with a suction pump using air/water channel cleaning adaptor.Manual cleaning was performed within one hour after the procedure and the device passed the leak test.During manual cleaning the detergent used was endofresh s.The instrument/suction channel, suction cylinder and the instrument channel port were brushed.The oer-4 automated endoscope reprocessor (aer) used was with endoquick detergent and acecide disinfectant.There were no defects on the aer.All channels were connected with cleaning tubes when the endoscope was set up into the aer.The expiration date of the disinfectant was controlled.The disinfectant solution met the minimum effective concentration.The device was dried by wiping with a clean towel/paper and stored without a drying cabinet.Olympus is the maintenance company.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that that the gastrointestinal videoscope / biopsy valve tested positive for an unexpected contamination.The issue was found during a routine culture.The bacteria - klebsiella pneumoniae (+) and serratia marcescens (+) were detected in the suction line/forceps plug.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.This report is related to linked patient identifier (b)(6) for the videoscope.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacture's (lm) review of the customer completed cleaning disinfection and sterilization (cds) checklist and the lms final investigation.The lm reviewed the customer provided the cds processes where no obvious deviations from instructions for use (ifu) were identified.The device history record (dhr) was unable to be reviewed for this device however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18504321
• Report Number: 9610595-2024-00825
• Device Sequence Number: 20820428
• Product Code: FDS
• UDI-Device Identifier: 04953170063947
• UDI-Public: 04953170063947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MB-358
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GIF-H290Z: GASTROINTESTINAL VIDEOSCOPE.
• Patient Sex: Unknown